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Influenza Vaccine Development

In response to the need to develop improved influenza vaccines protective against both seasonal influenza and avian influenza strains with the potential for pandemic outbreaks, the Vaccine Research Center (VRC) has initiated a program to develop novel vaccine approaches.

The first VRC investigational vaccine for clinical evaluation is an H5 DNA vaccine that builds on the existing VRC DNA plasmid platform technology. On December 15, 2006, the VRC received notice from the Food and Drug Administration (FDA) that the VRC's Investigational New Drug (IND) application for the H5 Influenza DNA vaccine was safe to proceed for clinical study. The VRC Clinical Trials Core started its first injection within two weeks. This investigational vaccine is the first product produced entirely within the VRC Vaccine Production Program (VPP) and the first vaccine manufactured at the VRC/VPP to be taken into a Phase I clinical study.

Developmental work is also ongoing with other candidate influenza vaccine approaches, such as recombinant adenoviral vector and protein subunit vaccines. Preclinical immunogenicity studies are underway testing vaccines consisting of H5 DNA alone; H5 protein alone; or an H5 DNA prime and recombinant adenoviral vector (rAd5) boost regimen encoding various gene products alone or in combination, including HA, NP and M2. Several initial candidate vaccines have shown promise in animal studies. NP and M2 will advance into clinical studies if ferret studies look as promising as mouse models with these genes in DNA/rAd.